Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 850 - MEDICAL CANNABIS DISPENSARIES
Subchapter 9 - LABORATORY CERTIFICATION, ANALYSIS, AND STANDARDS
Section 11-850-133 - Procedures for laboratory certification

Universal Citation: HI Admin Rules 11-850-133

Current through February, 2024

(a) To apply for a laboratory certification to analyze cannabis and manufactured cannabis products, a laboratory shall submit to the department on forms and in a manner prescribed by the department:

(1) An application;

(2) All information and documents required by the department, including but not limited to:
(A) Laboratory employee qualifications;

(B) Standard operating procedures;

(C) Quality assurance plan;

(D) Validation studies;

(E) Annual proficiency tests;

(F) A copy of the laboratory's most recent assessment by the laboratory's accreditation body, the laboratory's responses to any findings of noncompliance with standards or recommendations, and the corrective actions taken by the laboratory to address the findings or recommendations; and

(G) A copy of the laboratory's accreditation in Hawaii or another jurisdiction, accompanied by the scope of accreditation; and

(3) An annual certification fee in the amount of $3,000.

(b) As part of its review conducted prior to issuing certification to a laboratory, the department:

(1) Shall conduct an on-site evaluation of a laboratory seeking initial certification or a laboratory seeking to meet the requirements of section 11-850-132(b) after a period of provisional certification; and

(2) May conduct an on-site evaluation of a laboratory seeking renewal of certification.

(c) The department may issue a certification to a laboratory that meets the applicable requirements set forth in this chapter, including the requirements of section 11-850-132(b).

(d) The department may issue a provisional certification to a laboratory that meets the applicable requirements set forth in this chapter, including the requirements of section 11-850-132(c).

(e) The department shall deny certification to any laboratory that does not meet the requirements set forth in this subchapter.

(f) A laboratory certification pursuant to this subchapter shall expire one year after the date it is issued by the department.

(g) To apply for renewal of a laboratory certification, a laboratory shall submit the application, information, documents, and fee required in subsection (a) no later than two months prior to expiration of its certification.

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